Adipose Secretory Function in Patients Before & After Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495599
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Vanderbilt University

Brief Summary:
The central hypothesis of our study is that metabolic and hemodynamic improvements following gastric bypass surgery are mediated by downregulation of inflammation-related adipokines produced by the intra-abdominal adipose tissue such as Visfatin.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Cytokines assessed from fat tissue Phase 3

Detailed Description:

Central obesity represents a major risk for the development of type 2 diabetes and cardiovascular complications. Obesity is often associated with insulin resistance and abnormal production of inflammatory cytokines. Adipose tissue and especially omentum (adipocytes and resident macrophages) release several cytokines. Visfatin corresponds to a protein identified previously as pre-B cell colony-enhancing factor (PBEF), a 52-kilodalton cytokine expressed in lymphocytes. [1] Visfatin exerted insulin-mimetic effects in cultured cells and lowered plasma glucose levels in mice. Mice heterozygous for a targeted mutation in the visfatin gene had modestly higher levels of plasma glucose relative to wild-type littermates. Surprisingly, visfatin binds to and activates the insulin receptor.

Adipose tissue protein and mRNA expression of Visfatin (PBEF) has not been investigated in a single study design with regard to the relationship to fat distribution, insulin resistance and other metabolic risk factors, especially in morbidly obese individual undergoing weight loss surgery. Therefore, we propose the following specific aims: Investigate the protein and mRNA expression of Visfatin (PBEF) in the peripheral (subcutaneous) and visceral (omentum) adipose tissues of morbidly obese subjects and their relationships to the changes in body composition, fat distribution, insulin sensitivity and time-dependent reversal of co-morbidities following gastric bypass surgery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adipose Secretory Function in Patients Before & After Laparoscopic Surgery
Study Start Date : March 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Intervention Details:
    Procedure: Cytokines assessed from fat tissue
    Cytokines assessed from fat tissue

Primary Outcome Measures :
  1. The primary endpoint of the study is change in mRNA levels of Visfatin. [ Time Frame: Levels of Visfatin will be assayed from fat tissue taken before and after gastric bypass surgery or other laparoscopic surgery. ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with a BMI < 35undergoing laparoscopic surgery;
  • Patients undergoing bariatric surgery with a BMI >35kg/m2; and
  • Those patients who have had gastric by-pass that require additional surgical procedures are eligible for this research protocol.

Exclusion Criteria:

  • Unwilling to consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00495599

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Alfonso Torquati, M.D. Vanderbilt University Medical Center

Responsible Party: Vanderbilt University Identifier: NCT00495599     History of Changes
Other Study ID Numbers: 051215
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by Vanderbilt University:
Adipose Tissue
Gastric Bypass Surgery